FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 2800833
·
Received October 18, 2012
Report
- Report Number
- 1627487-2012-01873
- Event Type
- Injury
- Date Received
- October 18, 2012
- Date of Event
- September 24, 2012
- Report Date
- September 24, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2012-1874. IT WAS REPORTED THE PATIENT IS NO LONGER RECEIVING EFFECTIVE STIMULATION. AS SJM REPRESENTATIVE MET WITH THE PATIENT AND REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. SURGICAL INTERVENTION IS PENDING TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 3406009 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention | IMPLANT DATE:| SCS ANCHOR: MODEL 1192| IMPLANT DATE:| SCS ANCHOR: MODEL 1192| SCS IPG: MODEL 3788| IMPLANT DATE: |